• 제목/요약/키워드: Regulatory evaluation

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Cyber Security Risk Evaluation of a Nuclear I&C Using BN and ET

  • Shin, Jinsoo;Son, Hanseong;Heo, Gyunyoung
    • Nuclear Engineering and Technology
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    • 제49권3호
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    • pp.517-524
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    • 2017
  • Cyber security is an important issue in the field of nuclear engineering because nuclear facilities use digital equipment and digital systems that can lead to serious hazards in the event of an accident. Regulatory agencies worldwide have announced guidelines for cyber security related to nuclear issues, including U.S. NRC Regulatory Guide 5.71. It is important to evaluate cyber security risk in accordance with these regulatory guides. In this study, we propose a cyber security risk evaluation model for nuclear instrumentation and control systems using a Bayesian network and event trees. As it is difficult to perform penetration tests on the systems, the evaluation model can inform research on cyber threats to cyber security systems for nuclear facilities through the use of prior and posterior information and backpropagation calculations. Furthermore, we suggest a methodology for the application of analytical results from the Bayesian network model to an event tree model, which is a probabilistic safety assessment method. The proposed method will provide insight into safety and cyber security risks.

제품안전관리를 위한 나노물질 규제정책 도입평가 연구 (Study of the Introduction of a Nanomaterials Regulatory Policy for Product Safety)

  • 서정대
    • 한국산학기술학회논문지
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    • 제15권8호
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    • pp.4987-4998
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    • 2014
  • 최근 공산품에 나노기술의 활용이 점점 확대되고 다양한 나노제품이 출시되면서 나노물질의 인체 및 환경에 대한 유해성 문제가 주요한 사안으로 대두되고 있다. 이러한 위험성을 인식하여 EU 및 미국 등에서는 나노물질에 대한 규제를 강화하는 추세이다. 그러나 현재 국내에는 나노관련 법규가 미흡한 형편이다. 무엇보다도 소비자에게 밀접한 공산품의 나노물질 규제정책은 소비자의 안전을 위해 시급히 요구되고 있다. 이에 따라 본 연구에서는 규제정책 도입을 위한 기반연구로서 공산품에 함유된 나노물질에 대한 규제정책 도입을 위한 분석을 실시한다. 본 연구에서는 AHP(Analytic Hierarchy Process) 기법을 적용하여 규제정책을 평가하고 가장 적합도가 높은 최적 규제정책을 선택한다. 규제정책은 자율규제, 제품라벨링, 정부등록제를 대상으로 하며 정책평가기준은 시행성(효과성), 경제성, 수용성, 보호성으로 설정한다. 평가 결과 최대 적합도를 가지는 제품라벨링 정책을 최적 규제정책으로 선택한다.

Act on the Registration and Evaluation of Chemicals (K-REACH) and replacement, reduction or refinement best practices

  • Ha, Soojin;Seidle, Troy;Lim, Kyung-Min
    • Environmental Analysis Health and Toxicology
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    • 제31권
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    • pp.26.1-26.9
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    • 2016
  • Objectives Korea's Act on the Registration and Evaluation of Chemicals (K-REACH) was enacted for the protection of human health and the environment in 2015. Considering that about 2000 new substances are introduced annually across the globe, the extent of animal testing requirement could be overwhelming unless regulators and companies work proactively to institute and enforce global best practices to replace, reduce or refine animal use. In this review, the way to reduce the animal use for K-REACH is discussed. Methods Background of the enforcement of the K-REACH and its details was reviewed along with the papers and regulatory documents regarding the limitation of animal experiments and its alternatives in order to discuss the regulatory adoption of alternative tests. Results Depending on the tonnage of the chemical used, the data required ranges from acute and other short-term studies for a single exposure route to testing via multiple exposure routes and costly, longer-term studies such as a full two-generation reproducibility toxicity. The European Registration, Evaluation, Authorization and Restriction of Chemicals regulation provides for mandatory sharing of vertebrate test data to avoid unnecessary duplication of animal use and test costs, and obligation to revise data requirements and test guidelines "as soon as possible" after relevant, validated replacement, reduction or refinement (3R) methods become available. Furthermore, the Organization for Economic Cooperation and Development actively accepts alternative animal tests and 3R to chemical toxicity tests. Conclusions Alternative tests which are more ethical and efficient than animal experiments should be widely used to assess the toxicity of chemicals for K-REACH registration. The relevant regulatory agencies will have to make efforts to actively adopt and uptake new alternative tests and 3R to K-REACH.

Regulatory Disclosure of Large Business Groups in Korea

  • GWON, Jae-Hyun
    • Asian Journal of Business Environment
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    • 제10권1호
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    • pp.45-50
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    • 2020
  • Purpose: This paper examines the theoretical grounds for the disclosure of the Korea Fair Trade Commission. Three central measures of the disclosure are scrutinized: The interconnected status of affiliate companies, the important matters of private affiliates, and the large internal transactions. Contemplating on three measures, respectively, we review the rationale and derive policy implications. Research design, data, and methodology: Collecting the data of violation rates and remedial measures, we analyze the intensity of the disclosure enforcement. These statistics are critically reviewed by the economic literature of mandatory disclosure. Results: Statistics evince that the Korea Fair Trade Commission has enforced the regulatory disclosure quite successfully. Violation rates of the disclosure has declined from the outset. It demonstrates that the Korea Fair Trade Commission has enforced those measures satisfactorily for about a decade. But we cannot ascertain empirically whether the regulatory disclosures are socially and economically beneficial. To evaluate the effect of the regulatory disclosures precisely, we need a further empirical investigation. Conclusions: Despite the lack of policy evaluation, this study suggests complementary measures for current disclosures. First, disclosure of executive compensation in privately held subsidiaries must be introduced. Second, the controlling shareholder/manager should be responsible for information disclosure on foreign subsidiaries.

CURRENT RESEARCH AND DEVELOPMENT ACTIVITIES ON FISSION PRODUCTS AND HYDROGEN RISK AFTER THE ACCIDENT AT FUKUSHIMA DAIICHI NUCLEAR POWER STATION

  • NISHIMURA, TAKESHI;HOSHI, HARUTAKA;HOTTA, AKITOSHI
    • Nuclear Engineering and Technology
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    • 제47권1호
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    • pp.1-10
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    • 2015
  • After the Fukushima Daiichi nuclear power plant (NPP) accident, new regulatory requirements were enforced in July 2013 and a backfit was required for all existing nuclear power plants. It is required to take measures to prevent severe accidents and mitigate their radiological consequences. The Regulatory Standard and Research Department, Secretariat of Nuclear Regulation Authority (S/NRA/R) has been conducting numerical studies and experimental studies on relevant severe accident phenomena and countermeasures. This article highlights fission product (FP) release and hydrogen risk as two major areas. Relevant activities in the S/NRA/R are briefly introduced, as follows: 1. For FP release: Identifying the source terms and leak mechanisms is a key issue from the viewpoint of understanding the progression of accident phenomena and planning effective countermeasures that take into account vulnerabilities of containment under severe accident conditions. To resolve these issues, the activities focus on wet well venting, pool scrubbing, iodine chemistry (in-vessel and ex-vessel), containment failure mode, and treatment of radioactive liquid effluent. 2. For hydrogen risk: because of three incidents of hydrogen explosion in reactor buildings, a comprehensive reinforcement of the hydrogen risk management has been a high priority topic. Therefore, the activities in evaluation methods focus on hydrogen generation, hydrogen distribution, and hydrogen combustion.

융합산업 규제영향분석 프레임워크 개발: 신산업 분야별 규제이슈 사례 연구 (Development of the Regulatory Impact Analysis Framework for the Convergence Industry: Case Study on Regulatory Issues by Emerging Industry)

  • 송혜림;서봉군;조성민
    • 지능정보연구
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    • 제27권3호
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    • pp.199-230
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    • 2021
  • 산업의 경쟁력을 강화하기 위해서는, 새로운 기술의 개발 및 사업화와 함께 관련된 규제·애로를 발굴하고, 적기(適期)에 대응하는 것이 매우 중요한 요소로 작용한다. 현 정부에서는 이러한 산업적 변화에 대응하여 신산업에 대한 투자 확대와 함께 해당 산업 분야에 적용되고 있는 기존 규제메커니즘의 개혁을 추진하고 있다. 이러한 정부 정책방향에 맞춰, 본 연구는 신산업 분야에서 발생될 규제이슈를 선제적으로 예측하기 위해, 신제품 및 서비스의 시장진출에 있어서 걸림돌이 되는 기존 규제 제도를 발굴하고, 적정성 평가 및 개선방안을 마련하기 위한 규제영향분석 체계를 구축하고자 하였다. 그 결과로, 본 연구에서는 규제영향분석 프레임워크를 제시하였으며, 실제 규제이슈 사례를 적용하여, 분석하고 개선안을 도출하는 전반적인 과정을 보여주고자 하였다. 본 연구의 결과는 '18년도에 정부에서 집중적으로 투자를 진행했던 융합 신산업 분야의 제품 및 서비스를 대상으로 하여, 기획(R&D)단계부터 상용화 되기까지의 일련의 과정에서 발생 가능한 규제들을 사전적으로 검토하는 방법론을 제안하였다. 규제영향분석 프레임워크를 통해 도출된 규제 개선안은 소관 부처에 건의되어, 실제로 법령이 개정되었다는 점에서 연구의 실무적 및 정책적인 시사점을 제시할 수 있으며, 본 연구에서 개발한 규제영향분석 프레임워크는 향후 신산업 분야에서 나타날 수 있는 규제 이슈들을 해결하는 것에 도움을 줄 수 있을 것으로 예상한다.

소비목적과 광고유형이 규제적합성 및 제품평가에 미치는 영향 (Interactive Roles of Consumption Goals and Types of Advertisements on Regulatory Fit and Product Evaluation)

  • 최낙환;유총
    • 감성과학
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    • 제15권1호
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    • pp.73-86
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    • 2012
  • Consumers can have impression goals as well as defense goals. Those with impression goals could use social goals or opinions of others in a social context to determine their attitudes, and those with defense goals could maintain their existing attitudes and beliefs. Since people typically approach pleasure and avoid pain, there are two kinds of goal orientations depending on regulatory focus theory. Therefore, marketers could design advertisements for their products on the basis of two types of focus, promotion-focused and prevention-focused advertisements. This study aims to explore how consumers with different consumption goals evaluate an advertised product. The results of this study demonstrate that consumers with impression goals felt much more "right" about the product in a promotion-focused, rather than prevention-focused, advertisement, and those with defense goals, felt much more "right" about the product in a prevention-focused advertisement. Consumers with impression goals evaluated the product in the promotion-focused advertisement more favorably than in the prevention-focused advertisement, and those with defense goals evaluated the product in the prevention-focused advertisement more favorably.

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International Harmonization of Regulatory Quality Control and Quality Assurance of Drug

  • Kang, Chan-Soon
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.28-28
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    • 2003
  • After approval, the drug should be manufactured and maintained with uniform quality. To assure the quality of drugs, the drug companies should comply with GMP guidelines and regulatory authorities should assess their compliance. In this article, I want to review the definition of drugs as well as the quality surveillance system. To be controlled as drugs, they ought to have their own specifications and test methods. (omitted)

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시판 멸치액젓의 품질평가 방법에 관한 연구 (Quality Evaluation of Commercial Salted and Fermented Anchoby Sauce)

  • 김재현;류기형;안현주;이경행;이현자;변명우
    • 한국식품영양과학회지
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    • 제29권5호
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    • pp.837-842
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    • 2000
  • Commercially distributed salted and fermented anchovy sauces in Korea were purchased from six different companies. Microbiological, chemical, rheological and sensory analyses were carried out to evaluate the quality and safety and to provide basic information of the products. The salinity of every product was lower than of regulatory standard. All samples tested had acceptable in moisture content and pH. However, wide range of amino nitrogen (AN), volatile basic nitrogen(AN), volatile basic nitrogen (VBN), and trimethylamine (TMA) contents were observed. One product among tested had lower level of AN than regulatory standard. Pathogenic microorganisms were also detected from the samples, therefore sanitation procedure will be needed to ensure safety. From the results, AN, VBN, and viscosity were highly correlated to sensory scores, suggesting that these values can utilized as a standard method to evaluate quality of the salted and fermented anchovy sauce.

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Isolation of Human CYP4F2 genomic DNA and its $5^I$ End Regulatory Region Structure

  • Jin, Hyung-Jong
    • Archives of Pharmacal Research
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    • 제21권1호
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    • pp.35-40
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    • 1998
  • Human cytochrome P450 4F2 shows high regioselectivity in hydroxylation of stearic acid and leukotriene $ B_4.$ As a first step of its regulation study, human cytochrome P450 4F2 genomic DNA was isolated from liver of a person who was administered clofibrate for 10 years. From Southern hybridization, restriction enzyme digestion and sequencing experiments, isolated genomic DNA fragment was found to contain around 32 Kb DNA and more than 20 Kb of $5^I$ end regulatory region. Sequences of the structural gene region revealed exon 1 and exon 2. Further regulation studies would elucidate the feedback mechanisms of the oxidative degradation of fatty acids, inflammatory response and the clearance of leukotriene B4 in the liver. Furthermore, regulation study of this gene could explain the species difference in responses to peroxisome proliferator and help in the safety evaluation of peroxisome proliferating chemicals to human being.

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